As both an attorney and practicing gynecologist, Dr. François Blaudeau, the founder of Southern Med Law, provides perspective Zofran Information, specifically on claims put forth in birth defect cases regarding GlaxoSmithKline’s alleged off-label marketing of the anti-nausea medication as a treatment for morning sickness.
Southern Med Law announces the launch of a new Zofran Information page in response to the growing birth defects litigation involving the medication. As both a practicing gynecologist and attorney, Dr. François Blaudeau, the founder of Southern Med Law, possesses a unique understanding of the medical and legal questions relating to Zofran birth defect claims, including those involving the alleged off-label marketing of the anti-nausea medication as a treatment for morning sickness.
“Physicians, including gynecologists caring for pregnant woman, may prescribe medications for any purpose they see fit, whether or not a particular purpose is indicated on the drug’s label. However, pharmaceutical companies are not permitted to market their medications based on unapproved, off-label uses,” says Dr. François Blaudeau. “Whether or not GlaxoSmithKline improperly marketed Zofran to physicians as a safe and effective treatment for morning sickness is shaping up to be a key question in Zofran birth defect claims.”
Zofran, known generically as ondansetron, is approved to treat post-operative nausea and vomiting, as well as nausea and vomiting related to certain types of chemotherapy and radiography. While the drug has never been approved to treat pregnant women suffering from morning sickness, a recent analysis indicated that more than 1 million women annually have been prescribed some form of ondansetron off-label to treat nausea and vomiting related to pregnancy.
Court records indicate that a number of Zofran lawsuits have been filed in recent months on behalf of children who were allegedly born with serious birth defects due to pre-natal Zofran exposure. The first such complaint was filed in U.S. District Court, Eastern District of Pennsylvania , on February 12, 2015, and claims the drug was responsible for the heart birth defects suffered by two children. (Case 2:15-cv-00709-PDC) Another case filed on April 17, 2015 in the U.S. District Court, Eastern District of Texas, alleges that a mother’s use of Zofran during the first trimester of pregnancy caused her child to suffer a number of serious birth defects, including a heart murmur, fluid on the brain, thickened arteries and multiple developmental delays. (Case No. DRU-1505-14)
According to court documents, these lawsuits make similar claims regarding Glaxo’s alleged off-label promotion of Zofran as a morning sickness remedy. Among other things, the complaints point out that in 2012, the company reached a settlement with the U.S. Department of Justice that resolved charges over the tactics it used to market certain medications, including Zofran. Among other things, federal prosecutors had accused Glaxo of promoting the off-label use of Zofran for morning sickness.
(justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, DOJ, June 2012)
Based on his experience as a gynecologist and his insight into the frequency with which this medication has been prescribed to expectant mothers, Dr. Blaudeau believes that the Zofran litigation involving birth defects will continue to grow. He and his colleagues at Southern Med Law intend for the Firm’s new Zofran lawsuit page to serve as a valuable resource for those seeking to learn more about this important public health issue.
Southern Med Law is currently evaluating potential Zofran lawsuits on behalf of families who believe their child was born with a birth defect due to this medication. To learn more about the litigation involving Zofran and birth defects, please contact the Firm as soon as possible to learn more about your legal rights. You can arrange for a free, no obligation Zofran lawsuit review by calling Southern Med Law today, at 205-547-5525.
About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
Southern Institute for Medical and Legal Affairs
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526